Trial set for hip implant maker

By DAVID VOREACOS and JEF FEELEY Bloomberg News

Published: Thursday, January 24, 2013 at 1:00 a.m.

Last Modified: Wednesday, January 23, 2013 at 10:21 p.m.

One year after Johnson & Johnson pulled 93,000 metal hip implants from the market, the company internally estimated that 37 percent of the devices would fail within 4.6 years, according to newly unsealed court records.

A Johnson & Johnson ASR hip joint that was removed from a patient in
Anchorage, Alaska.NEW YORK TIMES PHOTO / JOSHUA BOROUGH / 2010

J&J faces 10,000 lawsuits over its ASR hips, which it pulled in August 2010 after citing U.K. joint registry data showing that more than 12 percent failed within five years. The estimate of triple the failure rate publicly cited by J&J came in documents unsealed Jan. 18 in the lawsuit of Loren Kransky in state court in Los Angeles.

Jurors are scheduled to hear opening statements Friday in Kransky's case, the first to go to trial against J&J, the world's biggest seller of health care products. J&J offered to pay more than $200,000 a case to settle most of the 10,000 lawsuits, according to five people familiar with the matter. The deal's cost could exceed $2 billion if most plaintiffs accept the terms. Lawyers for hip recipients have so far rejected the offer, the people said.

The failure-rate estimate came in pretrial testimony of Paul Voorhorst, a biostatistician for J&J's DePuy unit, which made the hips. A plaintiff's lawyer, Brian Devine, asked Voorhorst about a graph showing the company's review of 554 implanted hips through September 2011, and how many would fail, requiring follow-up replacement surgery known as revisions.

"That means that 37 percent are expected to fail at 4.57 years, correct?" Devine asked Voorhorst.

"The estimated revision rate at that time would be 37 percent," Voorhorst said. "That's correct."

Lorie Gawreluk, a DePuy spokeswoman, said that the company was "looking out for patient interests by analyzing data" on the ASR hip system.

She said the analysis cited by Voorhorst "was based on a small, limited set of data that could not be used to generalize the revision rate for ASR, unlike published data from national joint registries that include large numbers of patients and detailed revision information."

The J&J hips were made from a cobalt and chromium alloy used in two related models -- the ASR XL Acetabular System, and the ASR Hip Resurfacing System. In announcing its recall, J&J cited unpublished data from the U.K. showing that within five years, 13 percent of ASR XL hips failed and needed revision, and 12 percent of the ASR Hip Resurfacing System failed.

In March 2011, the British Orthopaedic Association and the British Hip Society said preliminary data put the ASR XL's failure rate in Britain as high as 49 percent after six years.

Lawyers for patients claim that debris from the metal ball sliding against the metal cup causes tissue death around the joint and may increase the amount of metal ions in the bloodstream to harmful levels. Patients who sued typically cite pain and say they are immobilized by joint dislocations, infections and bone fractures.

Claims by Kransky include failure to warn, negligent recall and manufacturing defect.

<p>One year after Johnson & Johnson pulled 93,000 metal hip implants from the market, the company internally estimated that 37 percent of the devices would fail within 4.6 years, according to newly unsealed court records.</p><p>J&J faces 10,000 lawsuits over its ASR hips, which it pulled in August 2010 after citing U.K. joint registry data showing that more than 12 percent failed within five years. The estimate of triple the failure rate publicly cited by J&J came in documents unsealed Jan. 18 in the lawsuit of Loren Kransky in state court in Los Angeles.</p><p>Jurors are scheduled to hear opening statements Friday in Kransky's case, the first to go to trial against J&J, the world's biggest seller of health care products. J&J offered to pay more than $200,000 a case to settle most of the 10,000 lawsuits, according to five people familiar with the matter. The deal's cost could exceed $2 billion if most plaintiffs accept the terms. Lawyers for hip recipients have so far rejected the offer, the people said.</p><p>The failure-rate estimate came in pretrial testimony of Paul Voorhorst, a biostatistician for J&J's DePuy unit, which made the hips. A plaintiff's lawyer, Brian Devine, asked Voorhorst about a graph showing the company's review of 554 implanted hips through September 2011, and how many would fail, requiring follow-up replacement surgery known as revisions.</p><p>"That means that 37 percent are expected to fail at 4.57 years, correct?" Devine asked Voorhorst.</p><p>"The estimated revision rate at that time would be 37 percent," Voorhorst said. "That's correct."</p><p>Lorie Gawreluk, a DePuy spokeswoman, said that the company was "looking out for patient interests by analyzing data" on the ASR hip system.</p><p>She said the analysis cited by Voorhorst "was based on a small, limited set of data that could not be used to generalize the revision rate for ASR, unlike published data from national joint registries that include large numbers of patients and detailed revision information."</p><p>The J&J hips were made from a cobalt and chromium alloy used in two related models -- the ASR XL Acetabular System, and the ASR Hip Resurfacing System. In announcing its recall, J&J cited unpublished data from the U.K. showing that within five years, 13 percent of ASR XL hips failed and needed revision, and 12 percent of the ASR Hip Resurfacing System failed.</p><p>In March 2011, the British Orthopaedic Association and the British Hip Society said preliminary data put the ASR XL's failure rate in Britain as high as 49 percent after six years.</p><p>Lawyers for patients claim that debris from the metal ball sliding against the metal cup causes tissue death around the joint and may increase the amount of metal ions in the bloodstream to harmful levels. Patients who sued typically cite pain and say they are immobilized by joint dislocations, infections and bone fractures.</p><p>Claims by Kransky include failure to warn, negligent recall and manufacturing defect.</p>